Simplified Insulin Protocol Using Lantus in Elderly - Full Text View

Purpose

The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.

Condition	Intervention	Phase
Diabetes	Drug: Glargine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Simplification of Diabetes Regimen in Elderly Patients Using Glargine

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Hypoglycemia

Drug Information available for: Insulin human Insulin glargine

U.S. FDA Resources

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:

Change in frequency and duration of hypoglycemia episodes [ Time Frame: baseline, 5 months, 8 months ] [ Designated as safety issue: Yes ]
frequency and duration of hypoglycemia measured by continuous glucose monitoring

Estimated Enrollment:	65
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Glargine We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.	Drug: Glargine Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults

Detailed Description:

As patients with diabetes age, adverse social and medical problems may arise. Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules. This may lead to errors in treatment and poor glucose control. Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months). The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 70 years or older
Diagnosis of diabetes mellitus Type II
At least 2 (short-acting or mixed) insulin injections per day
At least 1 episode of hypoglycemia (glucose value <70) on screening CGM

Exclusion Criteria:

Patients with the following illnesses in the past 12 months Myocardial infarction Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography Cerebrovascular event (stroke, TIA)
Active liver disease (history of cirrhosis or LFT > 3 times normal)
On dialysis or with severe renal dysfunction (creatinine clearance <20 ml/min)
Malignancy that limits life span to less than 18 months
Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480843

Contacts

Contact: Medha N Munshi, MD	617-632-8676	Medha.Munshi@joslin.harvard.edu
Contact: Christine Slyne, BS	617-309-4683	christine.slyne@joslin.harvard.edu

Locations

United States, Massachusetts
Joslin Diabetes Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Medha N Munshi, MD 617-632-8676 medha.munshi@joslins.harvard.edu
Contact: Christine Slyne, BS 617-632-8676 Christine.slyne@joslin.harvard.edu
Principal Investigator: Medha N Munshi, MD

Sponsors and Collaborators

Joslin Diabetes Center

Sanofi

Investigators

Principal Investigator:

Medha N Munshi, MD

Joslin Diabetes Center

More Information

Publications:

Narayan KM, Boyle JP, Geiss LS, Saaddine JB, Thompson TJ. Impact of recent increase in incidence on future diabetes burden: U.S., 2005-2050. Diabetes Care. 2006 Sep;29(9):2114-6. No abstract available.

[No authors listed] Economic consequences of diabetes mellitus in the U.S. in 1997. American Diabetes Association. Diabetes Care. 1998 Feb;21(2):296-309.

Bertoni AG, Kirk JK, Goff DC Jr, Wagenknecht LE. Excess mortality related to diabetes mellitus in elderly Medicare beneficiaries. Ann Epidemiol. 2004 May;14(5):362-7.

Blaum CS, Ofstedal MB, Langa KM, Wray LA. Functional status and health outcomes in older americans with diabetes mellitus. J Am Geriatr Soc. 2003 Jun;51(6):745-53.

Shorr RI, Ray WA, Daugherty JR, Griffin MR. Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med. 1997 Aug 11-25;157(15):1681-6.

Desouza C, Salazar H, Cheong B, Murgo J, Fonseca V. Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care. 2003 May;26(5):1485-9.

Frier BM. Hypoglycaemic valleys: an under-recognised problem in type 2 diabetes? Int J Clin Pract Suppl. 2002 Jul;(129):12-9. Review.

Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005 Dec;28(12):2948-61. Review. No abstract available.

Munshi M, Grande L, Hayes M, Ayres D, Suhl E, Capelson R, Lin S, Milberg W, Weinger K. Cognitive dysfunction is associated with poor diabetes control in older adults. Diabetes Care. 2006 Aug;29(8):1794-9.

Munshi MN, Hayes M, Sternthal A, Ayres D. Use of serum c-peptide level to simplify diabetes treatment regimens in older adults. Am J Med. 2009 Apr;122(4):395-7.

Kovatchev BP, Clarke WL, Breton M, Brayman K, McCall A. Quantifying temporal glucose variability in diabetes via continuous glucose monitoring: mathematical methods and clinical application. Diabetes Technol Ther. 2005 Dec;7(6):849-62.

Hendriksen C, Faber OK, Drejer J, Binder C. Prevalence of residual B-cell function in insulin-treated diabetics evaluated by the plasma C-etide response to intravenous glucagon. Diabetologia. 1977 Dec;13(6):615-9.

Faber OK, Binder C. C-peptide response to glucagon. A test for the residual beta-cell function in diabetes mellitus. Diabetes. 1977 Jul;26(7):605-10. PubMed PMID: 326604.

Montorio I, Izal M. The Geriatric Depression Scale: a review of its development and utility. Int Psychogeriatr. 1996 Spring;8(1):103-12. Review.

Arbuthnott K, Frank J. Trail making test, part B as a measure of executive control: validation using a set-switching paradigm. J Clin Exp Neuropsychol. 2000 Aug;22(4):518-28.

Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003 Jan;20(1):69-72. Review.

Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60.

Jacobson AM, de Groot M, Samson JA. The evaluation of two measures of quality of life in patients with type I and type II diabetes. Diabetes Care. 1994 Apr;17(4):267-74.

Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52.

Responsible Party:	Medha Munshi, Director, Joslin Geriatric Diabetes Program, Joslin Diabetes Center
ClinicalTrials.gov Identifier:	NCT01480843 History of Changes
Other Study ID Numbers:	2011-05
Study First Received:	November 9, 2011
Last Updated:	March 22, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:

simplification
glargine
elderly

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

Simplified Insulin Protocol Using Lantus in Elderly (SIMPLE)